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Notice Title

Provisional Consent to the Distribution of New Medicines

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Estradiol Transdermal System
Active Ingredient: Estradiol hemihydrate 0.585mg equivalent to estradiol 37.5mcg/24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Noven Pharmaceuticals Inc, Florida, United States of America
 
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for two years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other estradiol transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available to meet New Zealand market requirements, or to meet PHARMAC supply obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Estradiol Transdermal System
Active Ingredient: Estradiol hemihydrate 0.78mg equivalent to estradiol 50mcg/24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Noven Pharmaceuticals Inc, Florida, United States of America
 
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for two years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other estradiol transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available to meet New Zealand market requirements, or to meet PHARMAC supply obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Estradiol Transdermal System
Active Ingredient: Estradiol hemihydrate 1.17mg equivalent to estradiol 75mcg/24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Noven Pharmaceuticals Inc, Florida, United States of America
 
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for two years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other estradiol transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available to meet New Zealand market requirements, or to meet PHARMAC supply obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Estradiol Transdermal System
Active Ingredient: Estradiol hemihydrate 1.56mg equivalent to estradiol 100mcg/24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Noven Pharmaceuticals Inc, Florida, United States of America
 
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for two years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other estradiol transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available to meet New Zealand market requirements, or to meet PHARMAC supply obligations.
Note: This consent is valid for two years from the date of publication of this notice.


Dated this 30th day of May 2024.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

Publication Date
30 May 2024

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2024-go2592
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